This invention is directed to an apparatus and a process in utilizing that apparatus whereby a composition is located on the surface of the apparatus such that, upon introduction of the apparatus within a site in a body, the composition induces thrombosis followed by capillary and fibroblast infiltration and subsequent scar formation to fixedly hold the apparatus in position within the body.
In a paper entitled, "Ferromagnetic Silicone Vascular Occlusion In A Superconducting Magnetic Field Preliminary Report" Bulletin of the Los Angeles Neurological Societies, Vol. 37, No. 2, April, 1972, 67, I, along with my co-author, described a technique of arterial occlusion with silicone emboli as a means for treating unresectable angiomatous neoplasms. In that paper, we described the use of iron microspheres as a means of attempting to hold a vulcanizing silicone mass in position within an artery. A superconducting electromagnet was utilized to hold the iron shperes in a fixed position within the artery after introduction of the iron spheres and the components of the vulcanizing mass via a catheter. The iron spheres, in turn, were utilized to hold the vulcanizing mass in position until vulcanization was complete and a fixed body was formed within the artery.
This technique was extended to the treatment of cerebral aneurysms as was reported by me and the same co-author in "Treatment of Cerbral Aneurysms by Stereotaxic Ferromagnetic Silicone Thrombosis," Bulletin of the Los Angeles Neurological Societies, Vol. 38, No. 1, January, 1973, 21. The technique was further extended to infarction at a portion of an organ as reported in my and my co-author's paper entitled, "Ferromagnetic Silicone Vascular Occlusion: A Technique for Selective Infarction of Tumors and Organs", Annals of Surgery, Vol. 178, No. 5, November, 1973, 663.
As an improvement over the technique utilizing the external magnet to position the vulcanizing agent having iron particles suspended therein, a technique was later developed wherein a magnetic stereotaxic probe, which was shaped as a cylindrical magnet allowing for insertion of a long, thin needle through the center, was constructed. The magnet was of sufficient strength such that iron particles suspended in components capable of vulcanizing into an intact body, was introduced into an aneurysm or the like, by passing these components through the needle placed through the center of the magnet. The tip of the magnet was maintained in contact with the outside of the aneurysm or the like to maintain the position of the iron particles, and thus the vulcanized mass surrounding them, within the aneurysm for a period of time. Upon introduction of a metallic thrombosis, the magnet was removed, leaving a vulcanized mass including the iron particles therein to fill up the aneurysm and thus lessen the chances of rupture of the same with an accompanying hemorrhage. This work is reported in "Stereotaxy of the Human Brain", Edited by Schaltenbrand, G. and Walker, A. E., et al, Theime-Stratton, Inc., New York, 1982, page 674.
The use of balloons to temporarily or permanently occlude a vessel or the like was originally pioneered by Serbinenko, Journal of Neurosurgery, 41:125-145, 1974. Along with several co-authors in, "Development of Detachable Vascular Balloon Catheter", Bulletin of the Los Angeles Neurological Societies, Vol. 41, No. 1, January, 1976, 2, I describe the intercranial use of balloons for the occlusion of a vessel in an experimental animal. Further, in the article entitled, "Stereotaxy of the Human Brain" (op. cit.), further work with regard to the use of these balloons is described. The deflated balloon is inserted utilizing a catheter in an appropriate vessel or artery. Once in position, the balloon is inflated and techniques are available for detaching the balloon from the catheter, allowing withdrawal of the catheter once the balloon is inflated and is in position. The procedures of so utilizing balloons as described in these articles are herein incorporated by reference.
As is noted in my article described above, entitled, "Stereotaxy of the Human Brain", the presence of iron particles within the body results in the formation of a metallic thrombus. As noted in that article, this thrombus can then serve to seal or eliminate an aneurysm from the circulation.